Australia’s Therapeutic Goods Administration has approved Juluca, a two-drug, single pill for HIV that advocates have welcomed as a “step forward” for Australians living with HIV.
Juluca, which is a combination of dolutegravir and rilpivirine, is the first fixed-dose combination of a two-drug regimen for the treatment of certain adults with human immunodeficiency virus infection type 1 (HIV-1).
Advocates said the approval of the once-daily, single pill two-drug regimen, developed by specialist HIV company ViiV Healthcare, provides people with HIV (PWHIV) in Australia with an alternative option to the standard treatment regimen of three or more drugs.
A key challenge for the treatment of HIV is the growing ageing population of those requiring lifelong medication.
For example, a typical patient diagnosed with HIV in their 20s from 2008-2010 can now be expected to live to their 78th birthday, and advocates say many are concerned about the long-term effects of the treatment.
National Association of People with HIV Australia (NAPWHA) Vice President Robert Mitchell said the TGA’s approval of the pill marks an exciting step forward.
“As more options become available, PWHIV have the opportunity to choose treatments that not only control their HIV long term but ensures they can have a good quality of life over that time too,” he said.
“The community welcomes the news that they can now reduce the amount of medicine that is in their body to treat their HIV.”
ViiV Healthcare’s Australasia Medical Director Dr Fraser Drummond said the TGA’s approval “challenges the traditional approach of three-drug regimens that have been the standard of care for 20 years.”
“At ViiV Healthcare, we are passionate about continuing to optimise management of HIV by providing new treatment options that improve care,” he said.
ViiV Healthcare said they’ve made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) requesting the pill be subsidised for Australians living with HIV through the Pharmaceutical Benefits Scheme (PBS).
The US Food and Drug Administration approved Juluca back in November 2017, and the pill received marketing authorisation from the European Commission last month.
This month, a major Australian study was published that found that successful daily antiretroviral therapy (ART) effectively stops the transmission of HIV between gay and bisexual men.
The research backed up the findings of previous studies showing that men on treatment for HIV with an “undetectable viral load” cannot pass it on to other people.
In June, researchers announced that a promising candidate for a vaccine that protects against a number of strains would move to human trials in 2019.